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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director, Global Patient Safety Clinical Operations in Cambridge, MA, where you will provide functional expertise and Program level oversight and accountability of PV Activities globally, including set up and conduct of clinical studies from a PV perspective. You will partner with key stakeholders within and outside PV to ensure continuous harmonized operations of global Pharmacovigilance activities and maintain highest standards for integrated functioning.

As part of the Pharmacovigilance Operations team, you will report to the Director, PV Clinical Operations and will be responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials.

How you will contribute:

• Identify potential Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them

• Perform tasks of daily study specific activities including SAE reconciliation, study set up, TMF filing

• Perform certain key tasks to ensure high data quality and efficiency

• Support study specific Inspection and Audit requests pertaining to their program

• Conduct sample quality review of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms and completion instructions

• Review and create Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation within their program

• Maintain knowledge of PV Regulations and global industry practices for PV operational efficiency and compliance

• Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs, and other functional areas locally/globally on matters relating to Pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the company

• Ensure consistency in collection, processing to optimize evaluation of safety data stemming from clinical trials

• Represent Pharmacovigilance Operations on Global Program/study teams

Minimum Requirements/Qualifications:

• Bachelor’s required. Degree in scientific/medical field or advanced degree preferred.

• 8+ years of related pharmaceutical industry experience required.

• Experience in SAE reconciliation and safety management plans.

• Demonstrated skills in negotiation and consensus decision making.

• Expert knowledge of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements.

• Good cross-cultural understanding and experience.

• Critical thinking and analytical skills and ability to make high level decisions in cross- functional and global environments.

• Ability to review, analyze, interpret, and present complex data to a high standard.

• Understanding of and contribution to Takeda business needs and global strategy.

• Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.